Immunotherapy discontinuation and outcome: A multicenter real-life experience.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14075-e14075
Author(s):  
Maria Bassanelli ◽  
Diana Giannarelli ◽  
Maria RITA Migliorino ◽  
Marco Russano ◽  
Alain Gelibter ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Progressive Disease ◽  
Life Experience ◽  
Checkpoint Inhibitors ◽  
Real Life ◽  
Progression Free Survival ◽  
Complete Response ◽  
Response To Treatment ◽  
Best Response ◽  
Programmed Death

e14075 Background: Unlike chemotherapy, the optimum treatment duration with Immune checkpoint inhibitors (ICIs) is not clearly established. The aim of this study was to assess the outcome of patients (pts) who discontinued immune-based therapies for any reason except progressive disease. Methods: We conducted an observational, retrospective analysis of 46 consecutive pts with advanced cancer who received ICIs as clinically indicated, at eight Italian institutions. Tumor response to treatment was defined according to RECIST. Median overall survival (OS) and the 95% confidence interval (CI) were estimated with the Kaplan -Meier method. Results: 46 pts (median age 68 years [range 41-86]; male: 65.2%) with advanced cancer (n.39 non-small-cell lung cancer, n.15 renal cell carcinoma and n.2 melanoma) were treated with ICIs: 44 pts received programmed death 1 (PD-1) inhibitors (n.31 nivolumab, n.13 pembrolizumab) and 2 pts programmed death ligand 1 (PD-L1) (n.1 durvalumab, n.1 atezolizumab). A median of 8 cycles were administered [range 1 to 52]. 36 pts discontinued ICIs due to toxicities (diarrhoea, pneumonitis, hepatotoxicity) and 10 pts for reasons non immune-related. The median progression free survival (PFS) from the beginning of ICIs was 12.4 months (mo) [95% CI: 8.2-16.6] and the median OS was 20.0 mo (95% CI: 11.8-28.2). Median PFS from discontinuation of therapy was 5.0 mo [95% CI: 2.7-7.3] and median OS was 16.1 mo (95% CI: 5.4-26.8). Best response achieved according RECIST criteria were: 1 complete response (CR), 18 partial response, 21 stable disease (SD), 2 progressive disease (PR) and 3 non evaluable (NE). During interruption of ICIs 1 pts achieved a PR. Conclusions: This study shows the activity of ICIs, in terms of outcome and durable immune-response, in pts with advanced cancer even after treatment discontinuation.

Resting palliative chemotherapy in patients with gastric cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 122-122
Author(s):  
Hee Yeon Lee ◽  
Young Seon Hong ◽  
Hae Myung Jeon ◽  
Cho Hyun Park ◽  
Kyo Young Song ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Progressive Disease ◽  
Palliative Chemotherapy ◽  
Recurrent Disease ◽  
Progression Free Survival ◽  
Complete Response ◽  
Palliative Surgery ◽  
Free Survival ◽  
Best Response ◽  
Palliative Setting

122 Background: In gastric cancer, platinum and fluorouracil combination chemotherapy (CTx) is commonly used. But the optimal duration of CTx in palliative setting is not known. Thus, we reviewed the pts who rested CTx despite of persistent disease control. Methods: From Mar 2007 to Feb 2012 at Seoul St. Mary’s hospital, we retrospectively reviewed pts as follows; (1) had metastatic or recurrent gastric cancer, (2) received 9 cycles of FOLFOX as 1st-line, (3) had no progressive disease (PD) and rested after completion of 9th cycle. Results: Total 25 pts were reviewed. Median age was 54 (36~77) and 15 pts (60%) were male. 13 pts (52%) had recurrent disease and 12 metastatic initially. All pts were treated with oxaliplatin 100 mg/m2, leucovorin 400 mg/m2 on day 1 and 5-FU 1200 mg/m2 on day 1-2 every 2 weeks. All pts had metastasis; carcinomatosis peritonei (CP, 56%), lymph node (36%), liver (20%) and bone (8%). Nine pts (48%) had non-measurable lesions and 3 no evidence of disease (NED) on CT after palliative surgery. Response evaluation was done every 3 cycles. Among 22 pts with evaluable disease, 5 (20%) showed complete response (CR), 8 (32%) partial response (PR), 2 (8%) stable disease (SD) and 7 (28%) non-CR/non-PD as best response. Median progression free survival (PFS) was 14.2 m (95% CI, 6.6-21.9). The PFS in CP vs. non-CP was 9.9 vs. 21.5 m (log rank P = .037). And PFS according to best response were as follows; 25.5 m in CR + NED group, 15.7 PR, 13.4 non-CR/non-PD and 4.3 SD (log rank P = .014). Other factors did not seem to affect PFS. Conclusions: This study suggested that resting CTx in selected pts would be reasonable in gastric cancer. Especially the presence of CP and the grade of response seemed to be important in patient selection.

Lung cancer and immunotherapy: a real-life experience from second line and beyond

2019 ◽  
Vol 15 (26) ◽  
pp. 3025-3032 ◽  
Author(s):  
Fady El Karak ◽  
Fady Gh Haddad ◽  
Roland Eid ◽  
Maya Al Ghor ◽  
Elie El Rassy ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Median Overall Survival ◽  
Life Experience ◽  
Checkpoint Inhibitors ◽  
Real Life ◽  
Progression Free Survival ◽  
Second Line ◽  
Small Cell Lung ◽  
Standard Chemotherapy ◽  
Free Survival

Aim: This study assessed the efficacy of anti-PD-1/PD-L1 agents in real life when used in second line or beyond. Materials & methods: Patients with advanced non-small-cell lung cancer progressing after standard chemotherapy and receiving immunotherapy in the second line or beyond were included. Results: One hundred and ten patients were included with PD-L1 expression above 50%, between 1–49 and <1% in 38.6, 27.3 and 34.1% of patients, respectively. Checkpoint inhibitors were used as second, third and fourth line in 74.7, 21.8 and 3.5%, respectively. Partial response was observed in 25.6% of patients. Median progression-free survival was 4 months and median overall survival was 8.1 months. Conclusion: Immunotherapies are emerging as important tools in the oncologic field with good responses in real-life practice.

scholarly journals Real-life treatment of metastatic colorectal cancer with regorafenib: a single-centre review

2017 ◽  
Vol 24 (4) ◽  
pp. 234 ◽  
Author(s):  
J. Gotfrit ◽  
M. Vickers ◽  
S. Sud ◽  
T. Asmis ◽  
C. Cripps ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Confidence Interval ◽  
Real World ◽  
Survival Data ◽  
Progressive Disease ◽  
Performance Status ◽  
Real Life ◽  
Progression Free Survival ◽  
Best Response

Background Various tyrosine kinase signalling pathways affect the development and progression of colorectal cancer (crc). In clinical trials, regorafenib has been associated with a survival benefit in metastatic crc (mcrc). We assessed the safety and efficacy of regorafenib in real-world patients.Methods In a retrospective review of patients with mcrc treated with regorafenib at our institution from 2013 to 2015, patient demographics, treatment, and survival data were collected. Progression-free survival (pfs) and overall survival (os) were estimated using the Kaplan–Meier method.Results In total, 48 patients were offered regorafenib, and 35 (73%) started treatment. Of the patients who started regorafenib, 57% were men. Median age in the cohort was 61 years, and all patients had a performance status in the range 0–2. Time from diagnosis of mcrc to regorafenib treatment was more than 18 months in 71% of patients. Starting dose was 160 mg in 54% of the patients, 120 mg in 40%, and 80 mg in 6%. Dose reductions occurred in 34% of the patients, and interruptions, in 29%. Best response was progressive disease (60%) and stable disease (17%); response in the rest of the patients was unknown. The most common adverse events on regorafenib (any grade) were fatigue (57%), hyperbilirubinemia (43%), thrombocytopenia (37%), anorexia (31%), and hypertension (31%). The most common grade 3 or 4 adverse events were fatigue (29%), hypophosphatemia (17%), weight loss (11%), and hyperbilirubinemia (9%). Common reasons for discontinuing regorafenib included progressive disease (51%) and toxicity (26%). In patients treated with regorafenib, pfs was 2.4 months (95% confidence interval: 1.8 to 3.3 months) and os was 5.6 months (95% confidence interval: 3.7 to 8.9 months). No factors were associated with survival in univariate or multivariate analysis.Conclusions In a real-world setting, regorafenib is associated with survival similar to that reported in the randomized controlled trials, but at the expense of toxicity leading to discontinuation in many patients. Future studies of regorafenib should focus on identifying the patients most likely to benefit and on minimizing toxicity

Retrospective comparison of Cheson 2007 and Lugano classification criteria in independent review assessment of FDG-avid lymphomas.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19015-e19015
Author(s):  
Jayant Narang ◽  
Surabhi Bajpai ◽  
Rudresh Jarecha ◽  
Sayali Karve ◽  
Katarina Ludajic ◽  
...  
Keyword(s):  
Progressive Disease ◽  
Progression Free Survival ◽  
Complete Response ◽  
Blood Pool ◽  
Classification Criteria ◽  
Response To Treatment ◽  
Free Survival ◽  
Retrospective Comparison ◽  
Duration Of Response ◽  
Independent Review

e19015 Background: Revised Response Criteria in Malignant Lymphoma (Cheson 2007) and Lugano Classification are the most commonly used guidelines to assess response to treatment in lymphoma in clinical trials. While not drastically different from Cheson 2007, important clarifications and modifications were provided in Lugano Classification, specifically in the use of PET in response assessments. Methods: We retrospectively compared the blinded independent review of 25 subjects across multiple studies, assessed using Cheson 2007 and Lugano Classification on separate case report forms by the same reviewer per subject on 2 different dates. Focus was given on comparison of endpoint assessments of Progression-Free Survival (PFS), Duration of Complete Response (DOCR) and Duration of Response (DOR). Results: Assessments using Lugano Classification showed increased DOCR in 12% (3 out of 25), and DOR in 24% (6 out of 25) of the subjects. Cheson 2007 showed better DOR in 8% (2 out of 25) of the subjects. For PET positivity, Lugano Classification requires comparison with liver and mediastinal blood pool, whereas Cheson 2007 requires comparison to background or mediastinal blood pool. The results suggest that this difference in assessment of PET positivity (blood pool versus liver) leads to achieving Complete Response (CR) earlier, leading to longer DOCR and DOR when assessed using Lugano Classification compared to Cheson 2007. Lugano Classification also showed longer PFS in 16% (4 out of 25) of the subjects. When Progressive Disease (PD) was due to identification of new lesion(s), the two criteria showed similar PFS; however, when PD was due to lesion measurements and PET positivity assessment, Lugano Classification showed a longer PFS. Better PFS in Lugano Classification was observed because enlarging lymph nodes do not always show increased PET activity. Conclusions: In Independent review assessments for FDG avid lymphoma, using Lugano Classification showed better DOCR, DOR and PFS as compared to Cheson 2007. Further studies with increased number of subjects and intra-reader variability assessments are warranted to investigate the two criteria.

Discontinuation of immune checkpoint inhibitor (ICI) above 18 months of treatment in real-life patients with non-small cell lung cancer (NSCLC): INTEPI, a multicentric retrospective study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9082-9082
Author(s):  
Geoffroy Bilger ◽  
Nicolas Girard ◽  
Helene Doubre ◽  
Matteo Giaj Levra ◽  
Etienne Giroux Leprieur ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Disease Control ◽  
Fdg Pet ◽  
Metabolic Response ◽  
Real Life ◽  
Progression Free Survival ◽  
Complete Response ◽  
Subsequent Treatment ◽  
Duration Of Treatment ◽  
Best Response

9082 Background: The optimal treatment duration of ICIs for patients with NSCLC remains uncertain. In phase 3 clinical trials, treatment continued for two years or until disease progression, and results from CheckMate 153 trial suggest to continue beyond one year. Real life data are missing. Methods: This multi-centric retrospective study presents data on real-life patients who discontinued treatment after at least 18 months of ICI monotherapy, their tumour being still controlled. Their characteristics, the causes of discontinuation of ICI, and their outcome are described. Results: Between July 2015 and May 2018, 107 patients had their tumour controlled after at least 18 months of treatment. Among them, 54 (50%) patients discontinued ICI: 76% male, median age 63, 91% PS 0-1, 54% adenocarcinoma, 20% with brain metastases, PD-L1 expression level available for 18 (33%) patients (2 < 1%, 8 btw 1-50% and 8 > 50%), 93% treated after 1st line. The median duration of treatment was 26 months. Treatment was stopped by choice of the prescriber and toxicity in 46% and 22% respectively. With a median follow up of 21 months from ICI discontinuation, 18 (33%) patients had a tumor progression with a median time of 10 months (2-33). From discontinuation, overall survival (OS) and progression free survival (PFS) were 90% and 71% respectively at 12 months and 84% and 63% respectively at 24 months. Duration of disease control after ICI cessation seemed to be correlated to the best tumor response at treatment discontinuation, with a PFS rates at 12 months of 73% for complete response (CR n = 11), 77% for partial response (PR n = 37), 22% for patients with stable disease (SD n = 6), 80% for CR and/or complete metabolic response with 18F-FDG PET/CT (CMR) and 65% for others. Fourteen patients out of the 18 in the relapse group received a subsequent treatment : 7 were retreated with ICI (with best response 14% PR and 86% SD) and 5 received a localized therapy with 60% CR. Conclusions: Our study in real life provides new insight into the long-term outcomes of patients treated with ICI for at least 18 months before discontinuation in the absence of PD. CR and CMR with FDG-PET before therapy discontinuation may be a positive factor for a prolonged disease control upon discontinuation.

scholarly journals Validation of the Combined Biomarker for Prediction of Response to Checkpoint Inhibitor in Patients with Advanced Cancer

Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2316
Author(s):  
Jin-Chul Kim ◽  
You-Jeong Heo ◽  
So-Young Kang ◽  
Jee-Yun Lee ◽  
Kyoung-Mee Kim
Keyword(s):  
Advanced Cancer ◽  
Checkpoint Inhibitors ◽  
Gene Expression Signature ◽  
Progression Free Survival ◽  
Predictive Performance ◽  
Complete Response ◽  
Advanced Tumor ◽  
Formalin Fixed Paraffin ◽  
Number Of Patients ◽  
Formalin Fixed Paraffin Embedded

Although immune checkpoint inhibitors can induce durable responses in patients with multiple types of advanced cancer, only a limited number of patients have a known reliable biomarker. This study aimed to validate the IMmunotherapy Against GastrIc Cancer (IMAGiC) model, which was developed based on a previous study of four-gene and PD-L1 level, to predict immunotherapy response. We developed a clinical assay for formalin-fixed paraffin-embedded samples using quantitative real-time polymerase chain reaction to measure the expression level of the previously published four-gene set. The predictive performance was validated in a cohort of 89 patients with several advanced tumor types. The IMAGiC score was derived from tumor samples of 89 patients consisting of eight cancer types, and 73 out of 89 patients available for clinical response were analyzed with clinicopathological factors. The IMAGiC group (responder vs. non-responder) was determined with a specific value of the IMAGiC score as a cutoff, which was set by log-rank statistics for progression-free survival (PFS) divided the patients into 56 (76.7%) non-responders and 17 (23.3%) responders. Clinical responders (complete response/partial response) were higher in the IMAGiC responder group than in the non-responder group (70.6 vs. 21.4%). The median PFS of the IMAGiC responder group and non-responder was 20.8 months (95% CI 9.1-not reached) and 6.7 months (95% CI 4.9–11.1, p = 0.007), respectively. Among the 17 IMAGiC responders, 11 patients had tumor mutation burden-low and microsatellite-stable tumors. This study validated a predictive model based on a four-gene expression signature. Along with conventional biomarkers, our model could be useful for predicting response to immunotherapy in patients with advanced cancer.

scholarly journals LGG-25. A PHASE 2 STUDY OF TRAMETINIB FOR PATIENTS WITH PEDIATRIC GLIOMA WITH ACTIVATION OF THE MAPK/ERK PATHWAY. TRAM-01

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii371-iii371
Author(s):  
Sébastien Perreault ◽  
Valérie Larouche ◽  
Uri Tabori ◽  
Cynthia Hawkins ◽  
Sarah Lippé ◽  
...  
Keyword(s):  
Progressive Disease ◽  
Progression Free Survival ◽  
Complete Response ◽  
Serum Levels ◽  
Low Grade ◽  
Erk Pathway ◽  
Minor Response ◽  
Best Response ◽  
Duration Of Response ◽  
Braf Fusion

Abstract BACKGROUND Pediatric low-grade gliomas (PLGG) are the most frequent brain tumors in children. It is now known that the majority of PLGG have activation of the MAPK/ERK pathway. We hypothesize that we will observe responses in recurrent/refractory PLGG treated with trametinib. METHODS This is a multicenter phase II including three progressing/refractory PLGG groups: NF1 patients, KIAA1549-BRAF fusion patients and patients with other activation of the MAPK/ERK pathway (excluding V600E). Patients will receive daily oral trametinib for a total of 18 cycles of 28 days. A total of 104 patients will be enrolled in seven Canadian centers. Secondary objectives include the assessment of progression-free survival, tolerability of trametinib, serum levels of trametinib and evaluation of quality of life during treatment. RESULTS As of January 7 2020, 28 patients have been enrolled (NF1: 6 patients, KIAA1549-BRAF fusion: 17, other: 5 including 3 patients FGFR1 alteration). Median age is 8.5 years (range 2.5–25.4 years). Median follow-up is currently 4.6 months (range 0.16–14.7 months). Twenty patients are currently evaluable. Best response includes: 1 complete response (5%), 3 partial response (15%), 4 minor response (20%), 8 stable disease (40%), 4 progressive disease (20%). 8 patients (28,5%) discontinued treatment: 4 for progressive disease, 3 adverse event (alanine aminotransferase increase), 1 withdrew. CONCLUSION Trametinib is potential effective targeted therapy for patients with recurrent/refractory PLGG. Overall treatment is well tolerated. This ongoing trial will continue to gather data on response rate, duration of response and safety of trametinib for PLGG.

Melanoma: Prognostic Factors and Factors Predictive of Response to Therapy

2020 ◽  
Vol 27 (17) ◽  
pp. 2792-2813
Author(s):  
Martina Strudel ◽  
Lucia Festino ◽  
Vito Vanella ◽  
Massimiliano Beretta ◽  
Francesco M. Marincola ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Lactate Dehydrogenase ◽  
Checkpoint Inhibitors ◽  
Survival Rates ◽  
Elevated Serum ◽  
Predictive Biomarkers ◽  
Response To Therapy ◽  
Response To Treatment ◽  
Prognostic Features ◽  
Programmed Death

Background: A better understanding of prognostic factors and biomarkers that predict response to treatment is required in order to further improve survival rates in patients with melanoma. Predictive Biomarkers: The most important histopathological factors prognostic of worse outcomes in melanoma are sentinel lymph node involvement, increased tumor thickness, ulceration and higher mitotic rate. Poorer survival may also be related to several clinical factors, including male gender, older age, axial location of the melanoma, elevated serum levels of lactate dehydrogenase and S100B. Predictive Biomarkers: Several biomarkers have been investigated as being predictive of response to melanoma therapies. For anti-Programmed Death-1(PD-1)/Programmed Death-Ligand 1 (PD-L1) checkpoint inhibitors, PD-L1 tumor expression was initially proposed to have a predictive role in response to anti-PD-1/PD-L1 treatment. However, patients without PD-L1 expression also have a survival benefit with anti-PD-1/PD-L1 therapy, meaning it cannot be used alone to select patients for treatment, in order to affirm that it could be considered a correlative, but not a predictive marker. A range of other factors have shown an association with treatment outcomes and offer potential as predictive biomarkers for immunotherapy, including immune infiltration, chemokine signatures, and tumor mutational load. However, none of these have been clinically validated as a factor for patient selection. For combined targeted therapy (BRAF and MEK inhibition), lactate dehydrogenase level and tumor burden seem to have a role in patient outcomes. Conclusions: With increasing knowledge, the understanding of melanoma stage-specific prognostic features should further improve. Moreover, ongoing trials should provide increasing evidence on the best use of biomarkers to help select the most appropriate patients for tailored treatment with immunotherapies and targeted therapies.

scholarly journals Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany

2021 ◽  
Vol 9 (2) ◽  
pp. e001701
Author(s):  
Julia Maria Ressler ◽  
Matthias Karasek ◽  
Lukas Koch ◽  
Rita Silmbrod ◽  
Joanna Mangana ◽  
...  
Keyword(s):  
Chart Review ◽  
Progressive Disease ◽  
Overall Response Rate ◽  
Real Life ◽  
Retrospective Chart Review ◽  
Distant Metastases ◽  
Complete Response ◽  
Talimogene Laherparepvec ◽  
Metastatic Lesions ◽  
Melanoma Patients

BackgroundTalimogene laherparepvec (T-VEC) is a licensed therapy for use in melanoma patients of stage IIIB-IVM1a with injectable, unresectable metastatic lesions in Europe. Approval was based on the Oncovex Pivotal Trial in Melanoma study, which also included patients with distant metastases and demonstrated an overall response rate (ORR) of 40.5% and a complete response (CR) rate of 16.6%.ObjectivesThe aim of this study was to assess the outcome of melanoma patients treated with T-VEC in a real-life clinical setting.MethodsBased on data from 10 melanoma centers in Austria, Switzerland and southern Germany, we conducted a retrospective chart review, which included 88 patients (44 male, 44 female) with a median age of 72 years (range 36–95 years) treated with T-VEC during the period from May 2016 to January 2020.Results88 patients fulfilled the inclusion criteria for analysis. The ORR was 63.7%. 38 patients (43.2%) showed a CR, 18 (20.5%) had a partial response, 8 (9.1%) had stable disease and 24 (27.3%) patients had a progressive disease. The median treatment period was 19 weeks (range: 1–65), an average of 11 doses (range: 1–36) were applied. 39 (45.3%) patients developed adverse events, mostly mild, grade I (64.1%).ConclusionThis real-life cohort treatment with T-VEC showed a high ORR and a large number of durable CRs.

scholarly journals Treatment with therapeutic anticoagulation is not associated with immunotherapy response in advanced cancer patients

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Paul Johannet ◽  
Amelia Sawyers ◽  
Nicholas Gulati ◽  
Douglas Donnelly ◽  
Samuel Kozloff ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Advanced Cancer ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Progression Free Survival ◽  
Immune Checkpoint Blockade ◽  
Coagulation Cascade ◽  
Advanced Cancer Patients ◽  
Clinical Endpoints

Abstract Background Recent preclinical data suggest that there may be therapeutic synergy between immune checkpoint blockade and inhibition of the coagulation cascade. Here, we investigate whether patients who received immune checkpoint inhibitors (ICI) and were on concomitant anticoagulation (AC) experienced better treatment outcomes than individuals not on AC.Affiliation: Kindly confirm if corresponding authors affiliation is identified correctly.The corresponding author's affiliation is correct. Methods We studied a cohort of 728 advanced cancer patients who received 948 lines of ICI at NYU (2010–2020). Patients were classified based on whether they did (n = 120) or did not (n = 828) receive therapeutic AC at any point during their treatment with ICI. We investigated the relationship between AC status and multiple clinical endpoints including best overall response (BOR), objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and the incidence of bleeding complications.Affiliations: Journal instruction requires a country for affiliations; however, this is missing in affiliations 1 to 5. Please verify if the provided country is correct and amend if necessary.The country is correct for all affiliations (1 - 5). Results Treatment with AC was not associated with significantly different BOR (P = 0.80), ORR (P =0.60), DCR (P =0.77), PFS (P = 0.59), or OS (P =0.64). Patients who received AC were significantly more likely to suffer a major or clinically relevant minor bleed (P = 0.05). Conclusion AC does not appear to impact the activity or efficacy of ICI in advanced cancer patients. On the basis of our findings, we caution that there is insufficient evidence to support prospectively evaluating the combination of AC and immunotherapy.

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